Clinical trials: System Validation
Cystic Fibrosis
Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules
The purpose of this study is to validate the user interface of TOBI Podhaler by establishing that the product can support safe and effective use for the intended users
- Trial name
- NCT03502070
- Testing
- Tobi Podhaler
- Where
- 9 sites in United States
- Volunteers
- 47 people
- Sponsor
- Mylan Inc.
Gastroenteritis
Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.
- Trial name
- NCT05972733
- Testing
- HIL-214
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- HilleVax
Fluid Retention Tissue
Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device.
- Trial name
- MaTcH (NCT03072732)
- Testing
- u-Cor System, ZOE Fluid Status Monitor
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- Zoll Medical Corporation
Sleep Apnea
A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software.
- Trial name
- NCT04191668
- Testing
- NightOwl
- Where
- 3 sites in United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Sleep Apnea, Obstructive, Sleep Apnea, Central
DreamKit Respiratory Effort Signal Validation
This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.
- Trial name
- NCT04926077
- Testing
- DreamKit
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Inflammatory Bowel Disease, Perianal Fistula
Perianal Fistula (PAF) Validation and Burden of Illness Study
The purpose of this study is to gain a better understanding of the disease burden and unmet need of perianal fistulas within Crohn's disease (CD) in Ontario.
- Conditions
- Inflammatory Bowel Disease, Perianal Fistula, Crohns Disease
- Trial name
- NCT03981939
- Testing
- No intervention
- Where
- Canada
- Volunteers
- 3,032 people
- Sponsor
- Takeda
Alzheimer's Disease, Amnestic Mild Cognitive Impairment
[18F]MK-6240 Positron Emission Tomography (PET) Tracer First-in-Human Validation Study (MK-6240-001)
This 2-part, open-label study was designed to investigate the safety, tolerability, and efficacy of [18F]MK-6240, a Positron Emission Tomography (PET) imaging agent, for the quantification of neurofibrillary tangle (NFT)…
- Trial name
- NCT02562989
- Testing
- [18F]MK-6240, ~185 MBq, [18F]MK-6240, ~160 MBq
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pathology
Feature Detection Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
The objective of this study is to evaluate the repeatability and reproducibility of detection of histological features using whole slide imaging
- Trial name
- NCT03992768
- Testing
- Hamamatsu NanoZoomer S360MD Digital Slide Scanner System
- Where
- 3 sites in United States
- Volunteers
- 540 people
- Sponsor
- Hamamatsu Photonics K.K.
Rheumatoid Arthritis
Study for Validation of Standardized Questionnaires on Depression and Investigation of the Frequency of Depression in Rheumatoid Arthritis (RA) Participants
The purpose of this study is to validate standardized questionnaires on depression for RA and to investigate the frequency of depression with RA. The study will include 2 parts, VADERA I and VADERA II.
- Trial name
- NCT02485483
- Where
- 10 sites in Germany
- Volunteers
- 1,292 people
- Sponsor
- Hoffmann-La Roche
Obstructive Sleep Apnea
Validation of Safety and Efficacy for Night Shift Therapy
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
- Trial name
- NCT02032706
- Testing
- Deliver therapy when the supine position is detected
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Advanced Brain Monitoring, Inc.
Severe to Profound Mixed Hearing Loss
Clinical Assessment of the External Sound Processor Worn by Patients Implanted With Codacs
The purpose of this study is to evaluate the effect of the sound processor upgrade from the C-DACS investigational device Freedom sound processor to the Nucleus® CP810 sound processor for the Codacs™ system on the speech…
- Trial name
- NCT02156167
- Testing
- CP810 and Codacs™ system test
- Where
- Germany
- Volunteers
- 15 people
- Sponsor
- Cochlear
Diabetic Retinopathy
RETeval Study for Diabetic Retinopathy
RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy. The purpose of this study is to calibrate RETeval, and then measure its ability to detect vision threatening diabetic retinopathy.
- Trial name
- NCT01950663
- Testing
- RETeval
- Where
- 2 sites in United States
- Volunteers
- 468 people
- Sponsor
- Inoveon Corporation
Stroke, Acute Ischemic Stroke
Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s)…
- Trial name
- VOICE (NCT05547412)
- Testing
- NovaGuide 2 Intelligent Ultrasound System
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- NeuraSignal Inc dba NovaSignal
Surgery
Validation of Noninvasive Hemoglobin, Comparison of PVI to Standard Methods, and Validation of Clinical Efficacy of ORI
The study goal is to establish the correlation of hemoglobin values determined by the noninvasive pulse oximetry-determined hemoglobin (SpHb) system with hemoglobin as measured by other validated devices.
- Trial name
- NCT02841397
- Testing
- Masimo Pulse CO-Oximeter
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Masimo Corporation
GERD, Acid Reflux Disease
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).
- Conditions
- GERD, Acid Reflux Disease, Heartburn, Regurgitation
- Trial name
- C27 (NCT00703534)
- Testing
- AZD3355, Gelusil®
- Where
- 84 sites in United States
- Volunteers
- 478 people
- Sponsor
- AstraZeneca
Lymphoma, Non-Hodgkin
Dosimetry/Validation Study of 131Iodine-Anti B1 (Murine) Radioimmunotherapy for Chemotherapy Refractory Low Grade B Cell Lymphomas and Low Grade Lymphomas That Have Transformed to Higher Grade Histologies
Study RIT-II-001 is a phase II, multicenter study of the safety, tumor and organ dosimetry, dosimetry methods, and efficacy of Iodine-131 Anti-B1 Antibody for the treatment of patients with low-grade or transformed low-grade…
- Trial name
- RIT-II-001 (NCT01224821)
- Testing
- Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab
- Volunteers
- 47 people
- Sponsor
- GlaxoSmithKline
Skin Diseases, Skin Condition
Clinical Validation of AI-Based System for Continuous Remote Monitoring of Patient Severity - Experts' Opinion
The goal of this observational study is to learn if an artificial intelligence (AI) tool, called Legit Health Plus, can track the severity of chronic skin conditions from a distance.
- Trial name
- COVIDX_EVCDAO (NCT06237036)
- Where
- Spain
- Volunteers
- 160 people
- Sponsor
- AI Labs Group S.L
Sleep Apnea
Comparison of Breathing Event Detection by a Continuous Positive Airway Pressure Device to Clinical Polysomnography
The study is to compare the performance of a CPAP (continuous positive airway pressure) device to a clinical polysomnography (PSG) in identifying breathing events in patients with obstructive sleep apnea.
- Trial name
- NCT00836758
- Testing
- Analysis with AED and manual PSG scoring
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Philips Respironics
Growth Hormone Deficiency With Pituitary Anomalies
Validation of Macimorelin as a Test for Adult Growth Hormone Deficiency
The Macimorelin Growth Hormone Stimulation Test (GHST) will be compared with the Insulin Tolerance Test (ITT) in an open-label, randomized, 2-way crossover Trial.
- Trial name
- NCT02558829
- Testing
- Macimorelin, Insulin
- Where
- 27 sites in United States, Austria and 7 more
- Volunteers
- 157 people, healthy volunteers welcome
- Sponsor
- AEterna Zentaris
Leg Ulcer, Diabetic Foot Ulcer
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
The purpose of this reseach study is to determine Mölnlycke Health Care´s Leia dressing performance properties is fulfilled and that the dressing is safe when used on wound types such as pressure ulcer, leg ulcer, and diabetic…
- Conditions
- Leg Ulcer, Diabetic Foot Ulcer, Pressure Ulcer
- Trial name
- NCT01966380
- Testing
- Leia
- Where
- Sweden
- Volunteers
- 6 people
- Sponsor
- Molnlycke Health Care AB